Single and Multiple Ascending Dosing Administration of MF-300 in Healthy Participants

Part 1a is a double blind, randomized, placebo controlled, sequential SAD trial in healthy male or female volunteers. Volunteers will receive oral study drug (MF-300 or placebo) single dose administration. The dose levels will be tested sequentially until safety evaluation identifies a non-tolerated dose in the investigated population or when sustained MF-300 plasma levels are reaching the exposure supported by the available preclinical toxicokinetic data. Approximately 5 dose groups (non-elderly population) will provide a series increasing dose levels. An additional SAD dose group will evaluate an elderly population, with a dose selected based on safety and PK data from the 5 non-elderly SAD cohorts but not higher than what has been determined as generally safe and tolerated in the non-elderly population. Overall, no less than 48 subjects (assuming 6 cohorts of 8 subjects each) may complete the SAD study. One tolerated dose completed in Part 1a will be selected for the evaluation of food effect (Part 1b). The dose will be selected on the basis of accumulated safety and PK information from the SAD phase. Food effect assessment is to be performed using the non-elderly population only. The food effect study is a randomized, 2-period, 2-sequence, open-label, crossover study. Approximately 12 subjects will be randomly assigned to 1 of the 2 treatment sequences (6 subjects per sequence) in which they receive MF-300 following a 10-hour fast or following a high-fat breakfast. Part 2 is a double blind, randomized, placebo controlled, sequential MAD trial in healthy male or female volunteers. Volunteers will receive oral study drug (MF-300 or placebo) daily for 5 days as anticipated to achieved MF-300 steady state. The frequency of administration (once daily (QD)) and the duration of therapy required to achieve steady state (5 daily doses) were selected on the basis of allometric modeling from available toxicokinetic data but may be adapted based on MF-300 PK observed in the SAD cohorts previously completed. Three dose groups (non-elderly population) will provide a series increasing dose levels. The start of the MAD and SAD parts will be staggered, and a MAD dose cohort may be initiated when the corresponding SAD cohort at the next higher MF-300 dose has been cleared as safe and the food effect cohort has been completed. A fourth MAD dose group will be evaluated in the elderly population.